• 14/30281863 DC : 0

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    BS EN ISO 5364 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-10-2016

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Size designation and dimensions
    5 Materials
    6 Design
    7 Performance requirements
    8 Sterility assurance
    9 Packaging of oropharyngeal airways supplied
       sterile
    10 Marking
    11 Information to be supplied by the manufacturer
    Annex A (informative) - Rationale
    Annex B (normative) - Test method for resistance to
            collapse of the buccal portion
    Annex C (normative) - Test method for patency of
            lumen
    Annex D (informative) - Guidance on materials and
            design
    Bibliography
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential
             Requirements of EU Directive 93/42/EEC

    General Product Information - (Show below) - (Hide below)

    Comment Closes On
    Committee CH/121/5
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

    Standards Referencing This Book - (Show below) - (Hide below)

    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO/TR 11991:1995 Guidance on airway management during laser surgery of upper airway
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    EN 980:2008 Symbols for use in the labelling of medical devices
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